Background
Steve Obolewicz has over 30 years of in-depth experience within the military/ aerospace, automotive, consumer electronics, medical device and pharmaceutical industries in the areas of Quality/regulatory Management (FDA GMP/QSR and 21CFR820), Reliability Engineering, ISO 9000/QS-9000/TL 9000 Quality Systems, Quality Assurance, Total Quality Management and Malcolm Baldrige National Quality Award criteria.
Prior to joining SAI Global, Steve worked as a Quality Officer for a Fortune 100 company, prior to that he was Director of Program Management responsible for product development process, and also a Quality/Reliability Engineer and Manager for military, government and aerospace industries. He was also a Quality/Regulatory Specialist for a Medical Device and Diagnostics (IVD) company.
Steve led one of the first companies in the US to ISO 9001 registration, and he has been instrumental in developing and implementing total quality management initiatives in several major companies.
Specialties
One of Steve's strengths is his ability to link design engineering practices to manufacturing. He has implemented these links in both hardware and software development environments, helping to streamline the introduction of new products. In this role, Steve has provided customers with the direction how to integrate ISO 9001 or ISO13485 into business processes to create value and integrity.
Further, for our Medical Device manufacturing customers, he has advocated the proper use of FDA QSR per the Safe Medical Device Act. Lately, he has assisted several Medical Device companies with Risk Management in accordance with ISO 14971:2000 Also, Steve is a subject matter expert (SME) in TL 9000. He is a participant in the QuEST Forum teams (since 1998) for both TL 9000 handbooks, is an active member on sub-teams, and has been the key developer of the QuEST Forum sanctioned TL 9000 training courses. He has trained registrars, telecom service providers, and suppliers, as well as providing consulting services for some of the industries top suppliers.
Clients
As a Senior Consultant with SAI Global and as a former tutor for the BSI Lead Auditor course, Steve has trained more than 4,000 people. Some of Steve's client companies include: Hologic, Quidel, Biolitec, Juniper Networks, Extreme Networks, Corning Incorporated, Hewlett-Packard, General Electric, DaimlerChrysler, Applied Materials, Duracell, Dresser Industries, Stanley, Lucent, and Haynes International.
His key focus is on facilitating the implementation of a company specific, effective ISO 9001 quality system - not one that is "force-fit" into a company. Steve's expertise includes working with all organizational levels, establishing linkages with TQM and ISO 9001/13485, performing pre-assessments of quality systems, and developing a "customized" implementation plan for each client. He has performed numerous ISO 9001/13485 pre-assessments and internal audits.
Credentials
Steve received his BS in Physics from the University of New York in New Paltz, NY and his MBA from Marist College in Poughkeepsie, NY. Steve is a member of the ASQ. In addition, he is a member of the Project Management Institute (PMI), and the Institute for Environmental Sciences (IES). He is also an RAB Certified Quality Systems Lead Auditor since 1993.
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